The following data is part of a premarket notification filed by Tung Keng Enterprise Co., Ltd. with the FDA for Electrically Powered Wheelchair, Joy Rider.
Device ID | K220156 |
510k Number | K220156 |
Device Name: | Electrically Powered Wheelchair, Joy Rider |
Classification | Wheelchair, Powered |
Applicant | Tung Keng Enterprise Co., Ltd. No. 1, Lane 160, Sec. 2, Tan-Fu Road, Tan-Tzu Dist., Taichung City, CN |
Contact | Jen Ke-Min |
Correspondent | Jen Ke-Min Roc Chinese-European Industrial Research Society No. 58, Fu Chiun Street Hsin Chu, TW 30067 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-19 |
Decision Date | 2022-10-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04719884540026 | K220156 | 000 |
04719884540019 | K220156 | 000 |